Adhesive suture structure and methods of using the same

ABSTRACT

According to an aspect of the present disclosure, a surgical suture needle assembly is provided including an elongate tube defining a lumen through at least a portion of a length thereof; and a wound treatment material contained within the lumen of the suture structure. The present disclosure further provides for methods of using the surgical suture needle assembly in anastomotic procedures and the like.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 60/620,141, filed on Oct. 18, 2004, theentire disclosure of which is incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to suture structures andmethods of using the same and, more particularly, to suture structurescontaining a wound treatment material and the like and methods of usingthe same in anastomotic procedures and the like.

2. Discussion of Related Art

Throughout the years the medical field has utilized various techniquesin an effort to join or bond body tissue together. Historically,suturing was the accepted technique for rejoining severed tissues andclosing wounds. Suturing was historically achieved with a surgicalneedle and a suturing thread, and more recently, with a variety ofpolymeric or metallic staples, as will be discussed below. The intendedfunction of sutures is to hold the edges of a wound or tissue againstone another during the healing process so as to reduce discomfort, pain,scarring and the time required for healing.

Recently, many procedures which in the past required conventionalsuturing have been replaced by staple suturing which involves theapplication of the staples to the edges of the wound or tissue with theuse of a surgical stapler. Surgical staplers have been developed forjoining adjacent tissue, for providing hemostasis of adjacent tissue andfor providing hemostasis in conjunction with cutting of adjacent tissue.Such surgical staplers include both linear and annular typeconfigurations. A typical linear stapler and cutter includes parallelrows of staples with a slot for a cutting means to travel between therows of staples.

Typical linear type staplers are disclosed in commonly assigned U.S.Pat. No. 6,045,560 to McKean et al., U.S. Pat. No. 6,032,849 to Mastriet al., and U.S. Pat. No. 5,964,394 to Robertson, the entire contents ofeach of which are incorporated herein by reference. A typical annularstapler and cutter, including a plurality of annular rows of staples,typically two, and an annular blade disposed internal of the rows ofstaples, is disclosed in commonly assigned U.S. Pat. No. 5,799,857 toRobertson et al. and U.S. Pat. No. 5,915,616 to Viola et al., the entirecontents of each of which are incorporated herein by reference.

These types of surgical staplers secure adjoining body tissue forimproved cutting, join layers of tissue to one another and providehemostasis by applying parallel or annular rows of staples tosurrounding tissue as the cutting means cuts between the parallel orannular rows. Accordingly, by enabling a surgeon to perform all of thesetasks simultaneously, surgical staplers have been effective indecreasing the amount of time it takes to fasten tissue together. Toeven further enhance joining and hemostasis in instances where thestapler is used in highly vascularized tissue, surgical staplers withmultiple rows of staples have been used with a high degree of success.

Other surgical procedures utilize pledgets, buttresses or other types ofreinforcement materials and fabrics. These buttresses are typicallyplaced over the tissue contacting surface of the anvil and/or the tissuecontacting surface of the cartridge of the surgical stapling instrumentand secured against the target tissue during the firing of the surgicalstapling instrument. Reference may be made to U.S. Pat. No. 5,542,594,the entire content of which is incorporated herein by reference, for amore detailed discussion of the use of buttresses in cooperation withsurgical stapling instrument.

Still other surgical procedures involve the step of applying (e.g., byspraying, brushing, etc.) an adhesive material and/or a sealant materialto the external surface of the target surgical site following thesurgical stapling procedure.

Another procedure which has been developed includes the use ofbiological tissue adhesives have recently been developed for tissuerepair and the creation of anastomoses. Generally, biological adhesivesbond separated tissues together to aid in the healing process and toenhance the tissue strength. Such adhesives may be used instead ofsuturing and stapling for example in surgical procedures for the repairof tissue or the creation of anastomoses.

The application of a suitable biocompatible adhesive offers manyadvantages to the patient and the surgeon alike such as, for example,the avoidance of penetration of tissue by needles and/or staples, aswell as the immediate sealing of the tissue being treated. Moreover, useof a biocompatible adhesive tends to minimize foreign body reaction andscarring. Despite these advantages, however, the weakness along thetissue seam remains as a primary disadvantage in the use ofbiocompatible adhesives.

Accordingly, the need exists for surgical sutures which reduce thetrauma suffered by the patient, reduce the instances of leakage, reducethe instances of bleeding, and create a relatively strong bond betweenadjacent body tissues.

SUMMARY

The present disclosure relates to suture structures containing a woundtreatment material and the like and methods of using the same inanastomotic procedures and the like.

According to an aspect of the present disclosure, a surgical sutureneedle assembly is provided including an elongate tube defining a lumenthrough at least a portion of a length thereof; and a wound treatmentmaterial contained within the lumen of the suture structure.

The wound treatment material desirably includes at least one of anadhesive, a hemostat, and a sealant. The adhesive may include at leastone of a protein derived, aldehyde-based adhesive materials, andcyanoacrylate-based materials. The sealant may include at least one of afibrin sealant, a collagen-based tissue sealant, a syntheticpolymer-based tissue sealant, and synthetic polyethylene glycol-based,hydrogel materials. The hemostat may include at least one of afibrin-based, collagen-based, oxidized regenerated cellulose-based andgelatin-based topical hemostats, and fibrinogen-thrombin combinationmaterials. The wound treatment material may include a therapeutic agentwhich includes an antibiotic including at least one of gentamycinsulfate, erythromycin, and derivatized glycopeptides.

The wound treatment material may include at least one growth promotingfactor. The growth promoting factor may include at least one offibroblast growth factor, bone growth factor, epidermal growth factor,platelet derived growth factor, macrophage derived growth factor,alveolar derived growth factor, monocyte derived growth factor, andmagainin.

The surgical suture needle assembly may further include a suture needleoperatively connected to an end of the suture structure.

The suture structure may include at least one weakening element formedtherein. Accordingly, in use, the suture structure ruptures uponapplication of a compressive force thereto, whereby the wound treatmentmaterial is released therefrom.

The suture structure may be fabricated from one of a bio-absorbablematerial and a non-absorbable material. The non-absorbable material ofthe suture structure may include at least one of silk, polyamides,polyesters, polyethylene terephthalate, polyacrylonitrile, polyethylene,polypropylene, silk cotton, and linen. The bio-absorbable material ofthe suture structure may include at least one of a natural collagenousmaterial, and synthetic resins including those derived from glycolicacid, glycolide, lactic acid, lactide, dioxanone, polycaprolactone,epsilon-caprolactone, and trimethylene carbonate.

The suture structure may be a braid and the wound treatment material isimbedded in the braid.

According to another aspect of the present disclosure, a surgical sutureneedle assembly is provided including a suture structure; and a woundtreatment material at least one of incorporated into and onto the suturestructure.

According to the present embodiment, the suture structure may befabricated from one of a bio-absorbable material and a non-absorbablematerial. The non-absorbable material of the suture structure mayinclude at least one of silk, polyamides, polyesters, polyethyleneterephthalate, polyacrylonitrile, polyethylene, polypropylene, silkcotton, and linen. The bio-absorbable material of the suture structuremay include at least one of a natural collagenous material, andsynthetic resins including those derived from glycolic acid, glycolide,lactic acid, lactide, dioxanone, polycaprolactone, epsilon-caprolactone,and trimethylene carbonate.

In the present embodiment, the suture structure may be a braid and thewound treatment material may be imbedded in the braid.

The wound treatment material may include at least one of an adhesive, ahemostat, and a sealant. The surgical suture needle assembly may furtherinclude a suture needle operatively connected to an end of the suturestructure.

According to yet another embodiment of the present disclosure, a methodof performing a surgical anastomosis procedure is provided. The methodincludes providing a surgical stapling apparatus having a body portion,a staple cartridge assembly supported on a distal end of the bodyportion, and an anvil assembly selectively connectable to a distal endof the body portion in juxtaposed relation to the staple cartridgeassembly, and providing at least one suture needle assembly including asuture structure having a wound treatment material associated with thesuture structure.

The method further includes the steps of inserting the anvil assemblyinto a first intestinal section; suturing, with a suture needleassembly, the first intestinal section, about a shaft of the anvilassembly such that at least a portion of the suture structure extendsover a tissue contacting surface of the anvil assembly; inserting thedistal end of the stapling apparatus into a second intestinal section;suturing, with another suture needle assembly, the second intestinalsection to the staple cartridge assembly disposed at the distal end ofthe body portion of the stapling apparatus such that at least a portionof the suture structure extends into a tissue contacting surface of thestaple cartridge assembly; and connecting the shaft of the anvilassembly to the distal end of the body portion.

The method still further includes the steps of approximating the anvilassembly toward the distal end of the body portion to capture the firstand second intestinal sections therebetween and to release the woundtreatment material from the suture structure.

The wound treatment material may include at least one of an adhesive, ahemostat, and a sealant.

According to an embodiment, the suture structure may include a lumenextending at least partially therethrough, wherein the wound treatmentmaterial is contained within the lumen of the suture structure. Thewound treatment material may be incorporated into and/or onto the suturestructure.

The adhesive may include at least one of a protein derived,aldehyde-based adhesive materials, and cyanoacrylate-based materials.The sealant may include at least one of a fibrin sealant, acollagen-based tissue sealant, a synthetic polymer-based tissue sealant,and synthetic polyethylene glycol-based, hydrogel materials. Thehemostat may include at least one of a fibrin-based, collagen-based,oxidized regenerated cellulose-based and gelatin-based topicalhemostats, and fibrinogen-thrombin combination materials.

The wound treatment material may further include a therapeutic agent.The therapeutic agent may include an antibiotic including at least oneof gentamycin sulfate, erythromycin, and derivatized glycopeptides. Thewound treatment material may still further include at least one growthpromoting factor. The growth promoting factor may include at least oneof fibroblast growth factor, bone growth factor, epidermal growthfactor, platelet derived growth factor, macrophage derived growthfactor, alveolar derived growth factor, monocyte derived growth factor,and magainin.

It is envisioned that the suture structure may be fabricated from one ofa bio-absorbable material and a non-absorbable material. Thenon-absorbable material of the suture structure may include at least oneof silk, polyamides, polyesters, polyethylene terephthalate,polyacrylonitrile, polyethylene, polypropylene, silk cotton, and linen.The bio-absorbable material of the suture structure may include at leastone of a natural collagenous material, and synthetic resins includingthose derived from glycolic acid, glycolide, lactic acid, lactide,dioxanone, polycaprolactone, epsilon-caprolactone, and trimethylenecarbonate.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with a general description of the disclosure given aboveand the detailed description of the embodiments given below, serve toexplain the principles of the disclosure, wherein:

FIG. 1 is a perspective view of an exemplary prior art annular surgicalstapling device;

FIG. 2 is a perspective view of a needle assembly including a suturestructure according to an embodiment of the present disclosure;

FIG. 3 is a transverse cross-sectional view of the suture structure ofFIG. 2 as taken through 3-3 of FIG. 2;

FIG. 4 is a transverse cross-sectional view of a suture structureaccording to another embodiment of the present disclosure;

FIG. 5 is a transverse cross-sectional view of a suture structureaccording to yet another embodiment of the present disclosure;

FIG. 6 is a perspective view of the intestinal area of a patient,illustrating a method of using any of the suture structures of FIGS. 2-5in performing an anastomosis procedure;

FIG. 7 is a schematic perspective view of the intestinal area of FIG. 6,illustrating the anvil shaft mounted to the connection member of theannular stapling device;

FIG. 8 is a longitudinal cross-sectional view of the distal end of theannular stapling device following approximation of the anvil membertoward the staple pusher assembly; and

FIG. 9 is an enlarged view of the indicated area of detail of FIG. 8.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed suture structure and methods ofusing the same when performing an annular anastomosis will now bedescribed in detail with reference to the drawing figures wherein likereference numerals identify similar or identical elements. As usedherein and as is traditional, the term “distal” refers to that portionwhich is furthest from the user while the term “proximal” refers to thatportion which is closest to the user.

Referring initially to FIG. 1, an annular surgical stapling device, foruse with the suture structures disclosed herein, is generally designatedas 10. Surgical stapling device 10 includes a handle assembly 12 havingat least one pivotable actuating handle member 14, and an advancingmember 16. Extending from handle member 12, there is provided a tubularbody portion 20 which may be constructed so as to have a curved shapealong its length. Body portion 20 terminates in a staple cartridgeassembly 22 which includes a pair of annular arrays of staple receivingslots 36 formed in a tissue contacting surface 24 thereof. Each staplereceiving slot 36 having a staple 38 (see FIGS. 8 and 9) disposedtherein. Positioned distally of staple cartridge assembly 22 there isprovided an anvil assembly 30 including an anvil member 26 defining atissue contacting surface 29, and a shaft 28 operatively associatedtherewith for removably connecting anvil assembly 30 to a connectingmember 40 provided at a distal end portion of stapling device 10.

Staple cartridge assembly 22 may be fixedly connected to the distal endof tubular body portion 20 or may be configured to concentrically fitwithin the distal end of tubular body portion 20. Typically, staplecartridge assembly 22 includes a staple pusher 52 (see FIGS. 8 and 9)including a proximal portion having a generally frusto-conical shape anda distal portion defining two concentric rings of peripherally spacedfingers 52 a, 52 b (see FIGS. 8 and 9), each one of which is receivedwithin a respective staple receiving slot 36.

Typically, a knife 50 (see FIGS. 8 and 9), substantially in the form ofan open cup with the rim thereof defining a knife edge, is disposedwithin staple cartridge assembly 22 and mounted to a distal surface ofstaple pusher 52. The knife edge is disposed radially inward of fingers52 a, 52 b of staple pusher 52. Accordingly, in use, as staple pusher 52is advanced, knife 50 is also advanced axially outward.

Reference may be made to U.S. Pat. No. 5,915,616 to Viola et al., theentire content of which is incorporated herein by reference, for adetailed discussion of the structure and use of annular stapling device10.

Turning now to FIGS. 2 and 3, a suture needle assembly, including asuture structure in accordance with the present disclosure, is generallydesignated as 100. As seen in FIGS. 2 and 3, suture needle assembly 100includes a suture structure 102, in the form of an elongate tube,defining a lumen 102 a therethrough, and a wound treatment material “W”disposed and/or retained within lumen 102 a thereof.

As seen in FIG. 3, it is contemplated that suture structure 102 may beprovided with a weakening element 104 formed therein. For example,weakening element 104 may include and is not limited to, a line ofreduced thickness extending along at least a portion of the length ofsuture structure 102, a series of segments of reduced thickness, aseries of discrete pin-like weakening elements, and the like.Accordingly, in use, as a pressure on the exterior of suture structure102 increases, due to, for example, the compression forces created bythe approximation of anvil assembly 30 toward staple cartridge assembly22, suture structure 102 will rupture along weakening element(s) 104 atlower compression forces as compared to an elongate tube having noweakening elements 104. Additionally, if the pressure within lumen 102 aof suture structure 102 is increased, due to, for example, injectingmore wound treatment material “W” into lumen 102 a of suture structure102, suture structure 102 will also rupture along weakening element(s)104 at a force less than if no weakening element(s) 104 were provided.

Turning now to FIG. 4, in accordance with another embodiment of thepresent disclosure, a suture structure 112 is provided including anelongate core 112 a which is at least partially coated with woundtreatment material “W”. Preferably, wound treatment material “W” isdisposed or deposited around at least a portion of a perimeter of core112 a and along at least a portion of a length of core 112 a.

Turning now to FIG. 5, in accordance with yet another embodiment of thepresent disclosure, a suture structure 122 is provided and includes anelongate core 122 a, and a wound treatment material “W” dispersedthroughout core 122 a.

Turning back to FIG. 2, suture needle assembly includes a surgicalneedle 110 operatively connected to or secured to an end of any ofsuture structures 102, 112 or 122, disclosed herein, by any method knownin the art.

Suture structures 102, 112 and 122 may be fabricated from a wide varietyof natural and synthetic fibrous materials such as non-absorbable aswell as partially and fully bio-absorbable (i.e., resorbable) naturaland synthetic fiber-forming polymers. Non-absorbable surgical materialswhich are suitable for fabricating braided sutures include silk,polyamides, polyesters such as polyethylene terephthalate,polyacrylonitrile, polyethylene, polypropylene, silk cotton, linen, etc.Carbon fibers, steel fibers and other biologically acceptable inorganicfibrous materials can also be employed.

Desirably, suture structures 102, 112 and 122 are formed from absorbablesurgical materials. For example, any of suture structures 102, 112 and122 may be fabricated from natural collagenous material or syntheticresins including those derived from glycolic acid, glycolide, lacticacid, lactide, dioxanone, polycaprolactone, epsilon-caprolactone,trimethylene carbonate, etc., and various combinations of these andrelated monomers.

Additionally, suture structures 102, 112 and 122 may be fabricated froma block copolymer having one of the blocks made from hard phase formingmonomers and another of the blocks made from random copolymers of softphase forming monomers. Hard phase forming monomers include glycolideand lactide while soft phase forming monomers include 1,4 dioxane-2-oneand 1,3 dioxane-2-one and caprolactone. Preferably, the block copolymersused in forming surgical articles include one block having glycolic acidester units as a predominant component thereof. A “predominantcomponent” is a component which is present in an amount greater than 50mole percent. Exemplary block copolymers useful in forming surgicalelements and, in particular, suture structures 102, 112 and 122, aredescribed in U.S. Pat. No. 6,191,236, the entire contents of which areincorporated herein by reference.

The block copolymers may be formed into surgical articles (e.g., suturestructures 102, 112 and 122) using any known technique, such as, forexample, extrusion, molding and/or solvent casting. The copolymers canbe used alone, blended with other absorbable compositions, or incombination with non-absorbable components. A wide variety of surgicalarticles may be manufactured from the copolymers described herein. Theseinclude, but are not limited to clips and other fasteners, staples,sutures, pins, screws, prosthetic devices, wound dressings, drugdelivery devices, anastomotic rings, and other implantable devices.Fibers made from these copolymers may be knitted or woven with otherfibers, either absorbable or non-absorbable to form sutures, meshes orfabrics. Additionally, compositions including these block copolymers mayalso be used as an absorbable coating for surgical devices. Preferably,however, the copolymers are spun into fibers to be used as sutures,either monofilament or multifilament.

Multifilament sutures made from the copolymers described herein can beprepared by methods known in the art. Additionally, braid constructionssuch as those described in U.S. Pat. Nos. 5,059,213 and 5,019,093, theentire contents of each of which being incorporated herein by reference,are suitable for the multifilament sutures disclosed herein.

Suitable apparatus for the manufacture of monofilament sutures from theblock copolymers disclosed herein are described in U.S. Pat. No.5,403,347, the disclosure of which is incorporated herein in itsentirety by this reference.

It is envisioned that wound treatment material “W” may include and isnot limited to one of or a combination of adhesives, hemostats,sealants. Surgical biocompatible wound treatment materials which can bedisposed in support structure 102 or deposited on/in suture structures112 or 122, include adhesives whose function is to attach or holdorgans, tissues or structures, sealants to prevent fluid leakage, andhemostats to halt or prevent bleeding.

It is contemplated that the wound treatment material “W” may be abiocompatible sealant and/or adhesive, including, and not limited, tosealants which cure upon tissue contact, sealants which cure uponexposure to ultraviolet (UV) light, sealants which are two-part systemswhich are kept isolated from one another and are combined or anycombinations thereof. In one embodiment, it is contemplated that suchsealants and/or adhesives are curable. For example, the sealants and/oradhesives may have a cure time of from about 10 to 15 seconds may beused. In another embodiment, it is contemplated that a sealant and/oradhesive having a cure time of about 30 seconds may be used. Inpreferred embodiments, the sealant and/or adhesive is a bioabsorbableand/or bio-resorbable material.

In certain preferred embodiments, the wound treatment material “W”includes a sealant which is desirably a PEG-based material. Examples ofclasses of materials useful as the sealant and/or adhesive includeacrylate or methacrylate functional hydrogels in the presence of abiocompatible photoinitiator, alkyl-cyanoacrylates, isocyanatefunctional macromers with or without amine functional macromers,succinimidyl ester functional macromers with amine or sulfhydrylfunctional macromers, epoxy functional macromers with amine functionalmacromers, mixtures of proteins or polypeptides in the presence ofaldehyde crosslinkers, Genipin, or water-soluble carbodiimides, anionicpolysaccharides in the presence of polyvalent cations, etc. Examples ofsealants, which can be employed, include fibrin sealants andcollagen-based and synthetic polymer-based tissue sealants. Examples ofcommercially available sealants are synthetic polyethylene glycol-based,hydrogel materials sold under the trade designation CoSeal™ by CohesionTechnologies and Baxter International, Inc.

Surgical biocompatible wound treatment materials “W” which may be usedin accordance with the present disclosure include adhesives whosefunction is to attach or hold organs, tissues or structures. Examples ofadhesives which can be employed include protein derived, aldehyde-basedadhesive materials, for example, the commercially availablealbumin/glutaraldehyde materials sold under the trade designationBioGlue™ by Cryolife, Inc., and cyanoacrylate-based materials sold underthe trade designations Indermil™ and Derma Bond™ by Tyco HealthcareGroup, LP and Ethicon Endosurgery, Inc., respectively.

Some specific materials which may be utilized as adhesives includeisocyanate terminated hydrophilic urethane prepolymers derived fromorganic polyisocyanates and oxyethylene-based diols or polyols,including those disclosed in U.S. Pat. Nos. 6,702,731 and 6,296,607 andU.S. Published Patent Application No. 2004/0068078; alpha-cyanoacrylatebased adhesives including those disclosed in U.S. Pat. No. 6,565,840;alkyl ester based cyanoacrylate adhesives including those disclosed inU.S. Pat. No. 6,620,846; adhesives based on biocompatible crosslinkedpolymers formed from water soluble precursors having electrophilic andnucleophilic groups capable of reacting and crosslinking in situ,including those disclosed in U.S. Pat. No. 6,566,406; two part adhesivesystems including those based upon polyalkylene oxide backbonessubstituted with one or more isocyanate groups in combination withbioabsorbable diamine compounds, or polyalkylene oxide backbonessubstituted with one or more amine groups in combination withbioabsorbable diisoycanate compounds as disclosed in U.S. PublishedPatent Application No. 2003/0032734, the contents of which areincorporated by reference herein; and isocyanate terminated hydrophilicurethane prepolymers derived from aromatic diisocyanates and polyols asdisclosed in U.S. Published Patent Application No. 2004/0115229, thecontents of which are incorporated by reference herein. It iscontemplated that any known suitable adhesive may be used.

In certain embodiments, the wound treatment material “W” includeshemostats whose function it is to halt or prevent bleeding. Examples ofhemostat materials, which can be employed, include fibrin-based,collagen-based, oxidized regenerated cellulose-based and gelatin-basedtopical hemostats, as well as aluminum alum (i.e., ammonium alum oraluminum ammonium sulfate). Examples of commercially available hemostatmaterials are fibrinogen-thrombin combination materials sold under thetrade designations CoStasis™ by Tyco Healthcare Group, LP, and Tisseel™sold by Baxter International, Inc. Hemostats herein include astringents,e.g., aluminum sulfate, and coagulants.

It is envisioned that wound treatment material “W” may be a relativelylow viscosity fluid or liquid such that the wound treatment material “W”may freely flow from suture structure 102 upon rupturing thereof. It isfurther envisioned that wound treatment material “W” may include or bein the form of a fine powder of particulate material.

In other embodiments, wound treatment material “W” may include amedicament. The medicament may be disposed on structure 100 orimpregnated into structure 100. The medicament may include one or moremedically and/or surgically useful substances such as drugs, enzymes,growth factors, peptides, proteins, dyes, diagnostic agents orhemostasis agents, monoclonal antibodies, or any other pharmaceuticalused in the prevention of stenosis. For example, SilvaSorb™ availablefrom AcryMed, Inc., Portland, Oreg.

It is further contemplated that wound treatment material “W” mayinclude, for example, compositions and/or compounds which accelerate orbeneficially modify the healing process when particles of thecomposition and/or compound are applied to or exposed to a surgicalrepair site. For example, the wound treatment material “W” may be atherapeutic agent which will be deposited at the repair site. Thetherapeutic agent can be chosen for its antimicrobial properties,capability for promoting repair or reconstruction and/or new tissuegrowth. Antimicrobial agents such as broad spectrum antibiotic(gentamycin sulfate, erythromycin or derivatized glycopeptides) whichare slowly released into the tissue can be applied in this manner to aidin combating clinical and sub-clinical infections in a tissue repairsite. To promote repair and/or tissue growth, wound treatment material“W” may include one or several growth promoting factors, e.g.,fibroblast growth factor, bone growth factor, epidermal growth factor,platelet derived growth factor, macrophage derived growth factor,alveolar derived growth factor, monocyte derived growth factor,magainin, and so forth. Some therapeutic indications are: glycerol withtissue or kidney plasminogen activator to cause thrombosis, superoxidedimutase to scavenge tissue damaging free radicals, tumor necrosisfactor for cancer therapy or colony stimulating factor and interferon,interleukin-2 or other lymphokine to enhance the immune system.

Wound treatment material “W” may include visco-elastic film formingmaterials, cross-linking reactive agents, and energy curable adhesives.It is envisioned that wound treatment material “W”, and in particular,adhesive may be cured with the application of water and/or glycerin(1,2,3-pranatetriol, also known as glycerol and glycerine) thereto. Inthis manner, the water and/or glycerin cure the adhesive and hydrate thewound.

It is further envisioned and within the of the present disclosure forwound treatment material “W” to include any microbial agent, analgesic,growth factor, and anti-inflammatory agent known by one having skill inthe art or any combination thereof.

It is contemplated that it may be desirable to dye suture structures102, 112, 122 in order to increase visibility of the suture structure inthe surgical field. Dyes known to be suitable for incorporation insutures can be used. Such dyes include but are not limited to carbonblack, bone black, D&C Green No. 6, and D&C Violet No. 2 as described inthe handbook of U.S. Colorants for Food, Drugs and Cosmetics by DanielM. Marrion (1979). Preferably, suture structures 102, 112, 122 are dyedby adding up to about a few percent and preferably about 0.2% dye, andmost preferably about 0.06% to about 0.08% dye, such as D&C Violet No. 2to the resin prior to extrusion.

Turning now to FIGS. 6-9, there is illustrated the use of surgicalstapling device 10, together with suture needle assembly 100 includingsuture structures 102, in an anastomosis procedure to effect joining ofintestinal sections 66 and 68. The anastomosis procedure is typicallyperformed using minimally invasive surgical techniques includinglaparoscopic means and instrumentation. While the procedure is shown anddescribed using suture structures 102, it is envisioned and understoodthat suture structures 112 or 122 may be used equally herewith.

At the point in the procedure shown in FIG. 6, a diseased intestinalsection has been previously removed, anvil assembly 30 has been appliedto the operative site either through a surgical incision or transanallyand positioned within intestinal section 68, and tubular body portion 20of surgical stapling device 10 has been inserted transanally intointestinal section 66. Desirably, as seen in FIG. 7, intestinal sections66 and 68 have been temporarily secured (e.g., purse string sutured)about their respective components (e.g., shaft 28 of anvil assembly 30,and connecting member 40 of tubular body portion 20) by suture structure102 of suture needle assembly 100. Desirably, as seen in FIGS. 7-9, whenintestinal sections 66 and 68 is sutured to shaft 28 of anvil assembly30, and connecting member 40 of tubular body portion 20, needle 110 (seeFIG. 2) of suture needle assembly 100 is passed through or sewn throughintestinal sections 66 and 68 in such a manner that suture structure 102extends across staple pockets 24 of staple cartridge assembly 22 and/oracross staple anvil pockets 27 of anvil member 26.

The surgeon then maneuvers anvil assembly 30 until the proximal end ofshaft 28 is inserted into or otherwise operatively connected toconnecting member 40 of tubular body portion 20. Thereafter, as seen inFIG. 8, anvil assembly 30 and tubular body portion 20 are approximatedto approximate intestinal sections 66 and 68. Desirably, in oneembodiment, as seen in FIG. 9, anvil assembly 30 is approximated towardstaple cartridge assembly 22 by an amount sufficient to create apressure on suture structure 102 sufficient to rupture suture structure102 and release wound treatment material “W” between intestinal sections66 and 68.

In the event that suture structures 112 or 122 are used, the woundtreatment material “W” (e.g., adhesive) may be pressure activated. Inthis manner, in use, wound treatment material “W” is activated when thepressure between anvil assembly 30 and staple cartridge assembly 22exceeds a threshold level or some minimum level to activate theadhesive.

Turning now to FIG. 9, with anvil assembly 30 approximated toward staplecartridge assembly 22 and intestinal sections 66 and 68 clamped orcaptured therebetween, surgical stapling device 10 is fired therebystapling and adhering intestinal sections 66, 68 to one another. Uponfiring of surgical stapling device 10, staples 38 are driven from staplecartridge assembly 22 and driven through intestinal sections 66, 68thereby mechanically securing intestinal sections 66, 68 to one another.Simultaneously therewith, knife 50 severs the portions of intestinalsections 66, 68 located radially inward of knife 50 as well as seversany portion of suture structure 102 extending across knife 50 therebyfurther expelling wound treatment material “W” therefrom and ontointestinal sections 66, 68.

While several particular forms of the suture structures, and aparticular method of using the same, have been illustrated anddescribed, it will also be apparent that various modifications can bemade without departing from the spirit and scope of the presentdisclosure. For example, it is envisioned and within the scope of thepresent disclosure for an ultraviolet light activated wound treatmentmaterial (e.g., adhesive) to be used in connection with any of thesuture structures described above. Accordingly, in use, either prior toor following firing of surgical stapling device 10, the anastomosis siteis irradiated with UV light to thereby activate the adhesive.

In further embodiments, the surgical stapling device 10 is arranged fortransoral introduction into the body, such as for the treatment of theesophagus.

It is further contemplated that the suture structures described hereinmay be used in connection with an annular surgical anastomosing device,not including any staples for securing the intestinal sections together,which is capable of approximating, adhering and cutting tissue.

Thus, it should be understood that various changes in form, detail andapplication of the suture structures of the present disclosure may bemade without departing from the spirit and scope of the presentdisclosure.

1. A surgical suture, comprising: a suture structure including acylindrical wall defining a single, central lumen therethrough andextending along at least a portion of a length thereof, and at least oneweakened portion formed in an outer surface of the wall thereof, theweakened portion extending in a line of reduced thickness along at leasta portion of the length of the wall transverse to a transversecross-section of a circumference of the suture structure; and a woundtreatment material contained within the lumen of the suture structure,the weakened portion being arranged to allow the suture structure torupture upon application of a compressive force thereto, whereby thewound treatment material is released therefrom.
 2. The surgical sutureaccording to claim 1, wherein the wound treatment material is selectedfrom the group consisting of adhesives, hemostats, and sealants.
 3. Thesurgical suture according to claim 2, wherein the adhesives includematerials selected from the group consisting of protein derived,aldehyde-based adhesive materials, and cyanoacrylate-based materials. 4.The surgical suture according to claim 2, wherein the sealants includematerials selected from the group consisting of fibrin sealants,collagen-based tissue sealants, synthetic polymer-based tissue sealants,and synthetic polyethylene glycol-based, hydrogel materials.
 5. Thesurgical suture according to claim 2, wherein the hemostats includematerials selected from the group consisting of fibrin-based materials,collagen-based materials, oxidized regenerated cellulose-basedmaterials, gelatin-based topical materials, and fibrinogen-thrombincombination materials.
 6. The surgical suture according to claim 2,wherein the wound treatment material includes a therapeutic agent. 7.The surgical suture according to claim 6, wherein the therapeutic agentsinclude antibiotics including materials selected from the groupconsisting of gentamycin sulfates, erythromycins, and derivatizedglycopeptides.
 8. The surgical suture according to claim 2, wherein thewound treatment materials include at least one growth promoting factor.9. The surgical suture according to claim 8, wherein the growthpromoting factor includes materials selected from the group consistingof fibroblast growth factor, bone growth factor, epidermal growthfactor, platelet derived growth factor, macrophage derived growthfactor, alveolar derived growth factor, monocyte derived growth factor,and magainin.
 10. The surgical suture according to claim 2, furthercomprising a suture needle operatively connected to an end of the suturestructure.
 11. The surgical suture according to claim 10, where eachweakened portion of the suture structure includes at least one weakeningelement defining a line of reduced thickness extending along the lengthof the cylindrical wall of the suture structure.
 12. The surgical sutureaccording to claim 11, wherein the suture structure ruptures uponapplication of a compressive force thereto, whereby the wound treatmentmaterial is released therefrom.
 13. The surgical suture according toclaim 1, wherein the suture structure is fabricated from one of abio-absorbable material and a non-absorbable material.
 14. The surgicalsuture according to claim 13, wherein the non-absorbable material of thesuture structure is selected from the group consisting of silk,polyamides, polyesters, polyethylene terephthalate, polyacrylonitrile,polyethylene, polypropylene, silk cotton, and linen.
 15. The surgicalsuture according to claim 13, wherein the bio-absorbable material of thesuture structure is selected from the group consisting of naturalcollagenous materials, and synthetic resins including those derived fromglycolic acid, glycolide, lactic acid, lactide, dioxanone,polycaprolactone, epsilon-caprolactone, trimethylene carbonate.
 16. Thesurgical suture according to claim 1, wherein the single, central lumenis coaxially aligned with a central axis of the cylindrical wall.